Many common medications are counterfeited annually and could benefit from a simple means of verifying authenticity. It was estimated that on an annual basis consumers in western European countries spend at least $14 billion (USD) on counterfeit medications. Worldwide, counterfeit medications sold were estimate to reach about $75 billion (USD) in 2010. The counterfeit medications include drugs intended to treat Plasmodium falciparum (malaria), erectile dysfunction, obesity, influenza and other illnesses or conditions. Malaria infects between 200 and 500 million people per year worldwide. Nearly one million deaths per year occur, mostly in children five years old and younger, due to malaria. Fortunately, there is an effective therapy that is successful at treating the malaria. Unfortunately, many of the antimalarial medications delivered to patients are counterfeit. The World Health Organization found that in 2011 64% of antimalarial drugs were counterfeit. Often, the counterfeit manufacturers duplicate the pills so that they appear identical in color, shape, size, demarcation, blister packaging, etc. In some instances, the counterfeit medication contains no active ingredients with efficacy against malaria. These counterfeits can be any chemical agent that has a physical appearance similar to the active malaria drug, but has no pharmaceutical activity toward the disease. Non-limiting examples of these counterfeit agents include, but are not limited to, aspirin, acetaminophen, NSAIDs, vitamins, starch, cellulose, caffeine and other inert powdered agents. More sophisticated counterfeit medications can include a small amount of the active ingredient so that the medication satisfies qualitative testing. In such an instance, the medication will test positive for the presence of the active antimalarial ingredient, but it is not provided in an amount sufficient to be efficacious. Previously, it was found that certain antimalarial medications could be identified through colorimetric tests (U.S. Pat. No. 8,435,794); however, these methods and tests took an excessive amount of time—greater than 30 minutes to provide a discernable difference in color at 20° C. It was found the speed of the reaction could be increased under a temperature control of 40° C. However, this is undesirable as it would require temperature controlled parameters on the use of method. Thus, the amount of time required near room temperature or the need for a temperature controlled test made this colorimetric method impractical and ultimately undesirable. Thus, there is an immediate need to develop technologies and methods for authenticating malaria medications in a time quickly enough for necessary end use and that can be performed at room temperature. Further, there is a need for a testing method that not only provides qualitative results but also quantitative results.
Accordingly, it is an object of the present invention to provide technology and/or methods for identifying and authenticating malaria medications.
It is a further object of the present invention to provide technology and/or methods for identifying and authenticating malaria medications at room temperature.
It is still a further object of the present invention to provide technology and/or methods for identifying counterfeit medication, in particular, counterfeit malaria medication.
It is a further object of the present invention to provide technology and methods to provide rapid results in a matter of minutes.
It is yet a further object of the invention to provide technology and methods for quantifying the amount of active medication in a drug.